Lars Viktrup Beth A. Pangallo Michael J. Detke Norman R. Zinner
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Background: The efficacy and safety of
duloxetine, a dual reuptake inhibitor of serotonin and
norepinephrine at the recommended starting dose, have been
demonstrated in the treatment of major depressive disorder (MDD)
in men and women and in the treatment of stress urinary
incontinence (SUI) in women. Since the mechanism of action of
duloxetine in the treatment of SUI is believed to be related to
enhanced urethral closure forces, it is important to clarify the
risk of acute urinary retention.
Method: The relationship between
duloxetine and obstructive voiding symptoms was examined in 8
double-blind, 8- to 9-week, placebo-controlled studies and 1
open-label study in men and women treated for MDD with duloxetine
40 to 120 mg/day and in 4 double-blind, 12-week,
placebo-controlled studies and 4 ongoing open-label studies in
women treated for SUI with duloxetine 80 mg/day.
Results: In 378 men and 761 women with
MDD treated in placebo-controlled trials, 0.4% (4/1139; 3 men and
1 woman) of those treated with active medication reported
subjective urinary retention versus none (0/777) of those treated
with placebo (p = .15). In 958 women with SUI treated with
duloxetine in placebo-controlled trials, none reported subjective
urinary retention. Overall, in the duloxetine placebo-controlled
clinical studies in the treatment of MDD and SUI, obstructive
voiding symptoms (reported either as subjective urinary retention
or other obstructive voiding symptoms) occurred more often in
patients receiving duloxetine (1.0%, 20/2097) than in patients
receiving placebo (0.4%, 6/1732) (p < .05). Of the 4719 MDD
and SUI patients treated with duloxetine in placebo-controlled
and ongoing open-label studies, 2 men and 1 woman discontinued
because of obstructive voiding symptoms. Although such an
evaluation was not required by protocol, no cases of objective
acute urinary retention with postvoid residual urine verified
with a bladder scan or requiring catheterization were reported in
patients treated with duloxetine.
Conclusion: Duloxetine treatment in women
and men with depression and in women with SUI was rarely
associated with obstructive voiding symptoms, and no subjects had
objective acute urinary retention requiring catheterization.
Prim Care Companion J Clin Psychiatry 2004;6(2):65-73
https://doi.org/10.4088/PCC.v06n0204
© Copyright 2004 Physicians Postgraduate Press, Inc.